Report of the regional taskforce on prevention and control of substandard/spurious/falsely labeled/falsified/counterfeit
AbstractBACKGROUND 1. Medical products should meet the standards of quality, safety and efficacy. The quality of medical products is, however, a major public health concern to the World Health Organization and its Member States. Registered and unregistered medical products are often sold in most market in the African Region. The illegitimate manufacture, distribution, widespread availability and indiscriminate use of substandard/spurious/falsely labelled/falsified/counterfeit medical products have serious consequences on public health. 2. According to WHO definition, counterfeit medicines are medicines that are deliberately and fraudulently mislabelled with respect to their identity and/or source. The definition is applicable to both branded and generic products. Counterfeit medicines may include products with correct ingredients, with wrong ingredients, without active ingredients, with incorrect amounts of active ingredients or with fake packaging.3 Substandard medicines are products whose composition and ingredients do not meet the correct scientific specifications and are consequently ineffective and often dangerous to the patient. Substandard products may be the result of negligence, human error, insufficient human and financial resources or counterfeiting.4 All these factors may lead to medical products being ineffective and harmful.
Regional Committee for Africa, 60. (2011). Report of the regional taskforce on prevention and control of substandard/spurious/falsely labeled/falsified/counterfeit. http://www.who.int/iris/handle/10665/1674